Michael advises clients on the regulatory issues that arise throughout the life cycle of FDA-regulated medical devices, drugs, and biological products. He is particularly experienced in the review of promotional/marketing materials for FDA-regulated medical products, as well as the FDA’s evolving requirements for mHealth products, including mobile medical applications and clinical decision support software.

Michael regularly counsels clinical laboratories on federal (CLIA) and state regulatory issues, as well as the FDA’s ongoing efforts to regulate laboratory-developed tests (LDTs).

Michael also helps clients develop and implement strategies to persuade Medicare, Medicaid, and other third-party payers to establish adequate coverage and reimbursement for their products and/or the services in which their products are utilized.

Worked with a pharmaceutical company to draft substantive comments on documents outlining FDA’s proposed Engaged Center for Devices and Radiological Health leadership on issues related to proposed FDA oversight of LDTs

Assisted pharmaceutical and medical device companies in development and implementation of FDA-compliant strategies to facilitate establishment of third-party payer coverage, coding, and reimbursement policies

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